Monitoring/Instrumentation

Cleanroom Particle Counting: A Practical Guide to Classification and Continuous Monitoring Systems


This course will provide the attendee with a practical understanding of cleanroom classification and considerations for applying a Particle Monitoring System. A practical overview of using particle counters to classify various cleanrooms will be presented, starting with a brief discussion of particle technology.

Course outline     Who should attend?     Course materials     Instructor


Course outline
  • Overview
  • Particle technology
  • How to take meaningful measurements
  • How to interpret classification reports
  • Installation and operational qualification
  • Overview of EU GMP Annex 1 2008 and US FDA Aseptic Processing Guidance 2004
  • Factors to consider when selecting monitoring locations for particle sample probes in critical Grade A/B (ISO 14644-1 Class 5/6) zones
  • Strategies for monitoring lower grade/class zones
  • Action and alert limits
  • Importance of alarm notification
  • How to interpret data from a Particle Monitoring System
Who should attend?

Information coming soon.

Course materials
  • Copy of PowerPoint presentation in course binder
  • Certificate of attendance for completion of CEUs
Continuing Education Units: .6 CEUs

Instructor

 
 Troy Tillman